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Lead Evaluation for Defibrillation and Reliability Post Approval Study

Study acronym: LEADR PAS
StatusEnrolling by Invitation
PhaseNot specified
SponsorMedtronic
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 49 → 73 locationsv5
  2. Trial sites expanded: 29 → 49 locations
    • Start date changed from estimate of Feb 2026 to Jan 7, 2026
    v4
  3. Study sites: 13 to 29v3
  4. Start date: Sep 2025 to Feb 2026v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Medtronic
16 trials monitored
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Heart Disease
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Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release. The LEADR PAS is conducted within Medtronic's Product Surveillance Registry Platform (NCT01524276).
Trial Details
NCT Number NCT07005232
Lead Sponsor Medtronic
Conditions
(from sponsor)		 Tachyarrhythmia
Related terms Tachycardia
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov